Biologics made with brilliance

With decades of experience in taking your molecules from lab to patient, we’ve learnt invaluable lessons in the development and manufacturing of a wide range of biologics. At Pfizer we can help in the development and manufacturing of a range of therapeutic proteins and antibodies using expression in recombinant organisms including vaccine drug substance and intermediates, therapeutic proteins, monoclonal antibodies (mAbs), antibody drug conjugates (ADCs) and mAb biosimilars. Our global network of scientists, analysts and manufacturing experts are ready to help bring your breakthrough to light.

Collaborating with Pfizer CentreOne means accessing the expertise and experience of a partner that has been on the journey before and therefore reaching biologic clinical and commercial milestones with confidence.

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Capabilities at a glance

Biologics development capabilities

Cell culture medium development and optimization
Upstream and downstream process development and optimization
Full development of analytical methods
Scale-up from lab to pilot to commercial
Specification development
Regulatory support - pre and post-launch
Clinical manufacturing Ph I - III
Biosafety levels 1-2
Vaccines and monoclonal antibodies

Biologics manufacturing capabilities

Lyophilization of intermediates
Raw material sourcing
Cell bank storage
Wave expansion
GE X cellerex XDR 2000 bioreactor
Viral filtration
Tangential Flow Filtration (TFF)
Chromatography
Extractables and Leachables (E&L) studies
Comprehensive sterile filling capabilities including lyophilization and pre-filled syringe

Biologics Development

We provide you with access to biologics experience and compelling science to help you reach your key development milestones with confidence. Our team has rich experience in biologic development including gene and cell therapy scientist, leveraging many years of working in this space to build and optimise our gene and cell therapy platform. Access our capabilities and teams integrated with broader Pfizer technical and development expertise now.

Discover our biologics development expertise

Biologics Manufacturing

Harnessing Pfizer’s extensive scientific expertise and global manufacturing network, we deliver science at its best and global regulatory support to help bring your biologic to patients. We deliver end-to-end analytical and manufacturing expertise and provide molecule support from early clinical phases through to commercial launch. We leverage our development and technology transfer expertise to help bring your product to market as quickly as possible!

Discover our biologics manufacturing expertise

Expertise to bring your mammalian and microbial derived biotherapeutics to market, including monoclonal antibodies (mAbs)

Extensive experience

Proven history in producing therapeutic proteins and antibodies using expression in recombinant organisms
Therapeutic proteins, monoclonal antibodies (mAbs) and mAb biosimilars
Extensive testing experience, bioassays and protein-specific techniques
Partnering with customers to enable seamless integration across the entire lifecycle of your molecule

A solid foundation for success

Cell culture medium development and optimization
Upstream and downstream process development and optimization
Full development of analytical methods
Scale-up from lab to pilot to commercial
Clinical manufacturing Ph 1-3
Biosafety levels 1-2

Support with innovation and scalability

State-of-the-art manufacturing facilities located around the world
Single-use facilities with the ability to switch to stainless steel in solutions prep and centrifugation
Clinical manufacturing to commercial capability
Cold-chain handling and warehousing

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20+ years of antibody drug conjugate (ADC) innovation

Experts at the forefront of ADC progression

The world’s first commercial approved ADC product (Mylotarg™️)
Experts with advanced degrees and extensive ADC manufacturing experience
A track record of outstanding safety performance, successful technical transfers and on-time delivery

Integrated capabilities

End-to-end capability from cytotoxic compounds and drug substance intermediates to sterile drug products
Fermentation, recovery, chemical synthesis and purification capabilities
High-value formulations in a wide range of vial sizes and doses
The entire product flow path is single-use, eliminating the risk of product cross contamination and facilitating product changeover

Specialized facility to support ADCs’ unique needs

Pearl River ADC operation provides a full range of contract manufacturing services from a single site
Fully qualified facility producing commercial and clinical ADCs following cGMP practices
Approximately 94,000 sq ft of world-class manufacturing space
Site designed for cytotoxic drug processing
Bulk packing of vials in containment trays

Explore Pfizer Pearl River

Here to help bring your gene and cell therapy to light

Technical expertise

70+ experienced gene and cell therapy Pfizer scientists
Several years of experience from Pfizer’s internal research and pipeline optimization
Expertise developing and manufacturing scalable viral vectors across multiple serotypes

Capabilities and quality

World-class manufacturing space in North Carolina, USA (approximately 300,000 sq ft)
Clinical to commercial capability
Single-use mobile equipment Industry leading yield and productivity ratios
Batches ranging from 200-2000 liters
40+ GMP batches and 100+ transfections

Time is life

Global network of scientists, regulatory experts, and analytical and quality control engineers that help reduce:
- Wait times for manufacturing suite access
- Process scale-up time
- End-to-end process cycle time

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Vaccines made with compelling science and decades of expertise

Leveraging Pfizer’s history of expertise

Experience in producing therapeutic proteins in recombinant organisms
- Including vaccine drug substance/intermediates
Success in commercial and clinical trial material production
- Including critical vaccine starting material and protein drug substance intermediate (DSI)
Robust quality systems: reliable lyophilization vial and syringe drug product capability

Specialist solutions

Cold chain qualification and handling across entire manufacturing and packaging process
Process development (upstream, downstream, conjugation)
Analytical development and validation
Process characterization
Yields optimization expertise
Pfizer's robust quality systems

Full scope of manufacturing capabilities

Multi-product trains for manufacturing vaccine intermediates and drug substances for both commercial vaccines and clinical trial materials
- Pneumo DSI and DS, and polysaccharides and toxoid DSI
Large-scale microbial fermentation, purification, conjugation, cell banking
BSL 2+ facility design
Packaging and distribution

Explore our global manufacturing network

Expert Content

Read about Liposomal and Nanoparticle Technology at Pfizer Melbourne

Download White Paper

Read about our Large Molecule Biologic Expertise in our Brochure

Download Brochure

Read about the monoclonal antibody landscape in our technical application note

Download Application Note